FDA product code QHR

Blood Grouping Reagent

Hematology·Class U·21 CFR 660.20
US regulatory classifications
US Product Code (FDA)
QHR
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US Risk Class (FDA)
Class U
US Regulation (CFR)
21 CFR 660.20
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Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

For red blood cell antigen typing

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About this record

Blood Grouping Reagent is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.